Connective Tissue Graft Versus Collagen Matrix.

NCT04678804 | Completed Phase 4

• 1 other identifier: 808/2019/DISP/UNIPR
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the potential role of soft tissue thickness in maintaining gingival margin stability, the existing literature has mainly focused on investigating the effect of different surgical techniques on recession coverage percentage, without taking into account the changes in tissue thickness and biotype in the surgical area. Hence, this study aims to compare threedimensional scans of gingival recessions treated either with CAF+CTG or with CAF+PDCM by the use of a dedicated superimposition software at different healing timepoints. The primary outcome is to assess the change in mm3 and the distribution pattern of soft tissue thickening in the surgical area between autologous and heterologous grafts at 1, 3, and 6 months post-surgery. The secondary outcomes are: the complete root coverage at 6 months post surgery and Patients' Reported Outcomes (PROMS) measured with oral impact on daily performances (OIDP questionnaire) and on the evaluation of patients' perception about therapy.

Conditions

Gingival Diseases

Outcome Measures

Primary Outcomes (1)

• Soft tissue modifications

  to analyze and measure the soft tissue thickness modifications in the area of the graft with the three-dimensional superimposition technique. The measurement will be performed in cubic millimeters and the distribution will be analyzed with a colorimetric graphic map. The modifications will be compared between groups and between timepoints with an inter/intra group analysis.

  6 months

Secondary Outcomes (1)

• PROMS

  6 months

Study Arms (2)

Matrix Graft Group

EXPERIMENTAL

patients treated with Porcine Derived Volume Stable Matrix

Procedure: Mucogingival surgery for single recession coverage

Autogenous ctg group

OTHER

patients treated with autologous tissue

Procedure: Mucogingival surgery for single recession coverage

Interventions

Mucogingival surgery for single recession coverage PROCEDURE

The control group will be treated with a coronally advanced flap with vertical incisions (CAF) associated to an autologous connective tissue graft. The graft will be harvested from the palate in the area apical to the gingival margin of the second molar with an epithelial-connective harvesting technique to obtain a connective graft of 1 mm in thickness. Subsequently, the graft will be shaped in order to match height and width of the recipient site on the recession according to the technique proposed by Zucchelli in 2003. The test group will receive the same flap design with the same technique, then the porcine derived xenogeneic graft will be shaped in order to match height and width of the recipient site on the recession. In particular, the matrix will be reduced in thickness as suggested by the manufacturer to obtain a standardized thickness of 3 mm.

Autogenous ctg group; Matrix Graft Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy males and females ≥ 18 years old
• Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
• Clinical evidence of a single gingival recession (RT1, RT2)
• Full mouth bleeding and plaque scores (FMBS and FMPS) \< 20% recorded
• Non-surgical treatment completed within 6 months prior to assessment for eligibility

You may not qualify if:

• Medical history that includes diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
• Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
• History of alcohol or drug abuse.
• Smoking ≥10 cigarettes a day
• Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
• Taking medications that might induce gingival overgrowth (e.g. calcium antagonists)

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Centro Universitario di Odontoiatria

Parma, Italy

Location

Related Publications (4)

• Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.

  PMID: 21507033 RESULT

• Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.

  PMID: 27310522 RESULT

• Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.

  PMID: 3866056 RESULT

• Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.

  PMID: 14710766 RESULT

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Elena Calciolari, DDS

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: January 20, 2021
• Primary Completion: November 2, 2022
• Study Completion: May 18, 2023
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)